Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

K-Number: K242064 · 2025-01-17

ApplicantSmart Denture Conversions, LLC
Decision Date2025-01-17
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is a medical device manufactured by Smart Denture Conversions, LLC. It received FDA 510(k) clearance on 2025-01-17 under approval number K242064. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Smart Denture Conversions, LLC. The 510(k) number is K242064.

When was Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) approved by the FDA?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) received FDA 510(k) clearance on 2025-01-17, under approval number K242064.

What company makes Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is manufactured by Smart Denture Conversions, LLC.

What is the FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

The FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is NHA.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING NCT05252702 Aveir DR i2i Study COMPLETED

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑